| Primary Device ID | 00887517206176 |
| NIH Device Record Key | 55ea4009-bf92-46e5-a50c-1191d3508916 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Remote Monitoring |
| Version Model Number | 8010201 |
| Company DUNS | 053950783 |
| Company Name | Nuvasive, Inc. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | true |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Phone | +1(858)909-1800 |
| RA_UDI@nuvasive.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00887517206176 [Primary] |
| HAW | Neurological stereotaxic Instrument |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2019-11-25 |
| Device Publish Date | 2019-11-15 |
| 00887517213402 | Multimodality IOM Kit |
| 00887517212993 | RLN IOM Kit |
| 00887517212986 | EMG IOM Kit |
| 00887517212979 | MEP IOM Kit |
| 00887517212962 | SSEP IOM Kit |
| 00887517210838 | NV RM Needle Module, NVM5 IOM MEP/EMG |
| 00887517210821 | NV RM Needle Module, NVM5 IOM EMG |
| 00887517206695 | NV RM Module, NVM5 IOM SSEP |
| 00887517206688 | NV RM Surface Module, NVM5 IOM MEP/EMG |
| 00887517206671 | NV RM Surface Module, NVM5 IOM EMG |
| 00887517206183 | NV RM Surface Electrodes, IOM EMG Module |
| 00887517206176 | NV RM Needle Electrodes, IOM EMG Module |